The EU food risk assessor was asked by the European Commission to evaluate 58 flavouring substances - 56 acetals, one orthoester and one ester of a hemiacetal - in order to establish a list of authorised flavouring substances under regulation 1999/217/EC, as (amended by 2006/252/EC).
To estimate per capita intake of the substances in Europe, the Scientific Panel on Food Additives, Flavourings, Processing Aids, and Materials in Contact with Food used an approach derived from survey data known as the Maximised Survey-derived Daily Intakes (MSDIs) approach.
However, EFSA said that when the panel looked at data on use levels in foods supplied by the European flavouring industry, it found big differences.
"It appeared obvious that the MSDI approach in a number of cases would grossly underestimate the intake by regular consumers of products flavoured at the use level reported by the industry," said EFSA.
While the MSDI approach yielded results indicating that there would be no safety concern about any of the substances based on intake from their use as flavourings, an approach devised by EFSA based on the industry data found for 16 of the 58 intake data was above the threshold for concern.
"For these 16 substances more reliable exposure data are required," said EFSA. "On the basis of such additional data, these flavouring substances should be reconsidered using the procedure [set out in regulation EC1565/2000]."
"Subsequently, additional data might become necessary."
Other than data on acute toxicity, no toxicological studies were available on the 58 substances. EFSA said in its summary that the 58 are "expected to be metabolised to innocuous products".
However in the case of several of the acetals, methanol, formadeyde, ethanol and acetaldehyde are potential hydrolysis products. Under the MSDI intake level approach, none of the 56 acetals were found to be of concern.
Fifty-one of the flavouring substances occur naturally in foods.
The intake estimate gap was found to concern flavouring substances with small annual production values in particular.
The opinion was published in the EFSA Journal last week (2008, 642, 2-4), but was adopted in April 2007.
The full opinion can be found at http://www.efsa.europa.eu/EFSA/Scientific_Opinion/afc_op_ej642_FGE03-rev1_op_en.pdf.